Tarakaram Pappu

Total 12+ years’ experience in Quality Operations for Pharmaceutical industries in which 08+ years for Computer system validation (CSV) compliance and 04+ years for Shop floor compliance.

• Received Best performer of the month & year in Aurobindo pharma ltd.
• Successfully completion of new block qualifications with in the time line for Laurus & Aurobindo pharma ltd.
• Received recognition for completion of PMTS project implementation in Aurobindo pharma ltd., with in the time line.
• Successful completion of Data Migration Project in TCS for client.

• Responsible to perform GxP assessment, GAMP categorizations and identification of suitable Validation strategies for Applications or Computerized systems.
• Qualifying & validation of the Applications as per V-Model approach & Agile methodologies. Experience in the development, implementation and lifecycle management of computerized systems in regulated environments
• Responsible for Prepare and review of all levels of CSV validation documents as per US FDA 21 CFR Part 11 & EU Annex-11 guidelines.
• Review of User stories, URS, Design, functional specifications & technical documents.
• Review and Approving of validation documents like Validation plan, IQ and OQ Protocols, Requirement Traceability Matrix, and Validation Report.
• Review the IQ, OQ and PQ test scripts/ Protocols with annexures to verify that key aspects of the hardware and software installation adhere to pre-approved specifications in Quality/ Production Environments.
• Review & approve the periodic review reports for the GxP computerized systems and the associated gaps within CAPA Management System, Audit trails & backup schedules of the GxP computerized systems.
• Preparation and review of System Retirement & Data Migration plans.
• Coordinating with vendor for timely completion of Validation deliverables.
• Preparation and Periodic revision of VMP and validation related SOPs.
• Perform the Vendor or Supplier assessment as part of qualification..
• Change control management: Evaluation and approval of changes with impact assessment from quality and regulatory perspective.
• Conducting investigations to identify the possible root cause for any deviations from written procedures. Assessing the impact of the deviation and Identifying Corrective and Preventive actions to prevent recurrence and occurrence of the deviation.
• Performing Risk assessment studies for the processes and systems and preparing plans for mitigating risks with high severity by using Risk management tools.
• Compilation of investigation reports and related documents for their closure with prescribed documentation.
• Establishing procedures to mitigate the gaps identified during systemic assessments, regulatory inspections, internal audits and customer audits.
• Having knowledge on SDLC (Software development lifecycle) models. Good understanding in system application management (ITIL, ITSM, etc)

• RPA (Blueprism)
• MES (eDHR)
• PMTS (Pharma material tracking system)
• DSRS (Document storage & retrieval system)
• BMS (Building management system) & AMS (Artwork management system)
• QMS (Quality management sytem)
• LIMS, SAP & ERP
• Standalone Manufacturing, Packing Equipment’s & Analytical instruments software Qualification.

• Father's Name: Pappu Ganeswararao
• Date of Birth: 02/16/90
• Gender: Male
• Nationality: Indian
• Marital Status: Married
• Religion: Hindu

• Jira & HPALM
• SAP & ERP
• E-QMS & eDMS
• LIMS
• PMTS
• LMS & DMS
• Service now